Pharmaceuticals intended for oral administration are typically provided in solid form as tablets, capsules, pills, lozenges, or granules. Tablets are swallowed whole, chewed in the mouth, or dissolved in the oral cavity. Soft tablets that either are chewed or dissolve in the mouth are often employed in the administration of pharmaceuticals where it is impractical to provide a tablet for swallowing whole. With chewable tablets, the act of chewing helps to break up the tablet particles as the tablet disintegrates and may increase the rate of absorption by the digestive tract. Soft tablets are also advantageous where it is desirable to make an active ingredient available topically in the mouth or throat for local effects and/or systemic absorption. Soft tablets are also utilized to improve drug administration in pediatric and geriatric patients. Soft tablets designed to disintegrate in the mouth prior to swallowing are particularly useful for improving compliance of pediatric patients.
It has now been discovered that an orally disintegrating dosage form can be made from a mixture comprising at least one pharmaceutically active agent and at least one hydrated salt. Such process allows for the manufacture of dosage from (such as tablets) without the need of a compression or lyophillization processing step, which in turn, may assist in coated or taste-masked pharmaceutically active agent containing particles remaining intact during the manufacturing process.